The Economic Times daily newspaper is available online now.

    Dr Reddy's gets 11 observations from USFDA for Hyderabad plant

    Synopsis

    The audit of our formulations manufacturing plant-3 at Bachupally, Hyderabad by the USFDA has been completed today, said Dr Reddy's Lab.

    PTI
    NEW DELHI: Drug major Dr Reddy's Laboratories today said the US health regulator has issued 11 observations after inspecting its manufacturing plant in Hyderabad.

    "The audit of our formulations manufacturing plant-3 at Bachupally, Hyderabad by the USFDA has been completed today. We have been issued a Form 483 with 11 observations," Dr Reddy's Laboratories said in a regulatory filing.

    The observations by the US Food and Drug Administration (USFDA) are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems, it added.

    "We will address them comprehensively within the stipulated time," the drug firm said.

    Earlier this month, the USFDA issued two observations after inspecting company's manufacturing plant at Srikakulam in Andhra Pradesh.

    As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.

    The FDA Form 483 notifies the company's management of objectionable conditions.

    Dr Reddy's shares today ended 0.23 per cent up at Rs 2,599.15 a piece on the BSE.


    (You can now subscribe to our Economic Times WhatsApp channel)
    (Catch all the Business News, Breaking News Budget 2024 News, Budget 2024 Live Coverage, Events and Latest News Updates on The Economic Times.)

    Download The Economic Times News App to get Daily Market Updates & Live Business News.

    ...more
    The Economic Times

    Stories you might be interested in